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510(k) K790421

ROCHE LACTATE ANALYZER 640 by Roche Medical Electronics, Inc. — Product Code KHP

K790421 is an FDA 510(k) premarket notification submitted by Roche Medical Electronics, Inc. for the device "ROCHE LACTATE ANALYZER 640". The FDA issued a decision of Substantially Equivalent on May 15, 1979. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. Roche Medical Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1979
Date Received
February 28, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
Review Panel
CH
Submission Type

Other clearances by Roche Medical Electronics, Inc.

  • K791559 — ROCHE SENSOR ADAPTOR (November 21, 1979)
  • K791038 — FETASONDE UTERINE ACTIVITY MONITOR (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY MONITOR (September 4, 1979)
  • K791039 — FETASONDE FETAL HEART RATE VARIABILITY (September 4, 1979)
  • K791037 — FETASONDE LABOR STATUS DISPLAY (September 4, 1979)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K790761 — FETASONDE MODEL 2108 (June 1, 1979)
  • K782088 — MONITOR, HEART RATE MODEL 105 (January 4, 1979)
  • K782089 — MONITOR, HEART RATE MODEL 103 (January 4, 1979)
  • K781271 — MONITOR, PO2, INTRAVASCULAR (October 12, 1978)

Other clearances for product code KHP

  • K130113 — PICCOLO LACTATE TEST SYSTEM (March 11, 2013)
  • K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER (May 3, 2012)
  • K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (January 5, 2012)
  • K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (December 20, 2011)
  • K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (August 17, 2011)
  • K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (June 9, 2010)
  • K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (January 28, 2002)
  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K980908 — LACTATE PRO SYSTEM (September 11, 1998)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)

FDA data resources